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Pediatrics and Marketing Exclusivity
in the USA
The US Food and Drug Administration’s
1997 Modernisation Act, came into force on 1st
April 1999. The Act compels drug companies to provide the
FDA with clinical data on pediatric use for any drugs which
offer better treatment for, or will be widely used in children.
Under the Act, 493 drugs, earmarked as a priority by the
FDA, will be granted a six-month marketing exclusivity
in exchange for detailed pediatric data. To date, the FDA
has requested studies in children of 63 medicines, and about
30 drugs have qualified for the six months exclusivity
extension.
In the US the first flurry
of marketing exclusivity applications have been granted.
The first drugs, predictably to gain six months’ pediatric
extension, are the mature high selling drugs namely ranitidine
and ibuprofen. But interestingly a new biotechnology
drug, abacavir has also gained a pediatric extension
as can be seen from IMS HEALTH’s monthly drug patent monitoring
service, Patents
International.
Pharmaceutical companies have
often been reluctant to carry out clinical trials in children.
It is very difficult to get parents’ consent for their children
to take part in clinical trials. Pediatricians have to face
the unenviable task of considering the pros and cons of
treating a child for the "off label" indication. In addition
the pediatric market is relatively small. IMS HEALTH's Medical
Dynamics service shows that only 6.8% of prescriptions
in the US retail sector are written for children less than
3 years old and a further 7% of prescriptions are written
for children aged four to 12 years old.
Whilst the R&D pharmaceutical
companies welcome this legislation, the generics companies
in the US view it as an unfair delay in their marketing
plans geared around top selling drug’s patent expiries.
However, the industry’s request for an injunction
to stop the FDA's program to encourage pediatric research
on the safe and effective use of medicines for children
was denied on April 20th. A US Federal
Court ruled that it would not be in the public interest
for the injunction to go ahead. Patents
International will follow any cases that result in litigation.
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